Executive Summary

After being adopted by the European Parliament in April 2014,

the European Union’s Clinical Trials Regulation (Regulation (EU)

No 536/2014) will officially take effect on January 31, 2022. The regulation aims to improve the harmonization of the approval process for clinical trials and make the region more attractive

as a destination for clinical research.

As a privately owned and operated contract research organization headquartered in Switzerland, PSI CRO has continuously monitored and adapted to the changing European regulatory landscape over the last 25 years. Drawing on this experience, we can offer a unique perspective on preparing for this shift in how clinical trials are conducted in the EU.

Europe’s share of global clinical trials activity has decreased over the last ten years, falling from 25.6% to 19.3% in 2020 [1]. Nevertheless, the region remains a hotbed for biotech innovation, with half of today’s biotech companies based in France, Germany, and the United Kingdom [2]. And for companies like those developing cell and gene therapies in challenging indications, Europe is a necessary element for conducting successful global clinical trials, with its sizeable patient population – roughly three times as much as the equivalent US cohort for select indications [3].

These statistics highlight a significant untapped opportunity for sponsors looking to conduct research in the region – a situation that the new Clinical Trials Regulation is designed to address. However, if you are a sponsor of active clinical trials in the European Union, you may have additional responsibilities under the new Clinical Trials Regulation. This white paper highlights the new elements introduced by the EU CTR, the applicability for current studies, and how to transition your study to the new requirements.